Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study | NCT07745543

NCT07745543

Overview

NCT ID: NCT07745543
Lead Sponsor: University Hospital, Basel, SwitzerlandOTHER
Official Title: Redo-Pulmonary Vein Isolation Using Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Atrial Fibrillation: A Multi-Centre Randomized Clinical Trial: The REDO-PIFPAF-PFA Study
Brief Summary: The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.
Conditions: Atrial Fibrillation (AF)
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Jul 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.

Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.

Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.

Age ≥ 18 years at the time of informed consent.

Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

Previous LA surgery

> 1 prior LA ablation

LA ablation outside of the PVs in the first LA ablation

LA diameter >60 mm in the parasternal long axis

Patients in persistent AF lasting >3 years

AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)

Pre-existing PV stenosis or PV stent

Pre-existing hemidiaphragmatic paralysis

Contraindication to anticoagulation or radiocontrast materials

Prior mitral valve surgery

Severe mitral regurgitation or moderate/severe mitral stenosis

Myocardial infarction during the 3-month period preceding the consent date

Ongoing triple antithrombotic/anticoagulation therapy

Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/transcatheter aortic valve implantation procedure

Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including a patent foramen ovale)

New York Heart Association (NYHA) class III or IV congestive heart failure

Left ventricular ejection fraction (LVEF) <35%

Hypertrophic cardiomyopathy or left septal wall thickness >1.5 cm

Significant chronic kidney disease (eGFR <30 ml/min)

Uncontrolled hyperthyroidism

Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date

Ongoing systemic infections

Cardiac amyloidosis

Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)

Life expectancy less than one year per physician opinion

Currently participating in any other clinical trial, which may confound the results of this trial.

Unwilling or unable to comply fully with the study procedures and FU.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 270Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Patrick Badertscher, PD Dr. med.Contact
patrick.badertscher@usb.ch

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